Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendments
In the reply filed 6/24/2026, Applicant has amended Claims 1, 12, and 16, and cancelled claims 4-11, 13-15, and 19.
Claims 1-3, 12, 16-18 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/24/2026 was filed after the mailing date of the non-final Office action on 3/24/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Claim Objections
The objection to Claim 1 has been withdrawn due to Applicant’s amendment.
Claim Objections
Claims 2 and 3 are objected to because of the following informalities: claim 2 uses the past tense, while claim 3 uses the present tense. It is recommended to match claim tense and use the present tense whenever possible.
Claim 16 is objected to because of the following informalities: instant claim uses the term “PAM2CSK”, which has a typographical error and should recite “PAM2CSK4”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 3 recites “the TLR agonists” and Claim 18 recites “the at least two TLR agonists” to Claim 1. There is insufficient antecedent basis for these limitations in the claims because Claim 1 is directed to PAM2CSK4 and ODNM362. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 12 draws to a method of administering ODNM362 that has a phosphodiester backbone, which does NOT narrow the scope of claim 1 where the method comprises administering ODNM362, which being an oligonucleotide (see p.3 of Applicant’s specification) already has phosphodiester backbone. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Allowable Subject Matter
In view of Applicant’s amendments to the claims and arguments of record, the rejections of record are withdrawn.
The prior art does not teach or fairly suggest the synergistic method for treating type I hypersensitivity comprising administering a composition comprising PAM2CSK4 and ODNM362.
Specifically, Figure 1 of Applicant’s specification demonstrates that the combination of elements provide a synergistic effect on lowering IgE levels to an allergen. For example, Fig. 1C demonstrates that co-administration of ODNM362 (“ODN”) and PAM2CSK4 (“Pam2”) together lowered IgE levels from about 4.36 (column 6) to about 1.26 (column 4), which is about a 3.12 difference. By contrast administration of ODNM362 (“ODN”) and PAM2CSK4 (“Pam2”) individually only lowered IgE levels by about 1.36 and 0.86 (see columns 7 & 8, respectively), which is a total of 2.22 (see also Example 1, p. 63, [0179]). Thus, the combination lowered IgE levels greater than the sum of the ODNM362 and PAM2CSK administered individually, thereby producing a synergistic effect.
Withdrawn 35 USC § 103
The prior rejection of Claims 1-3, 17-18 under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007, see IDS filed 11/06/2023) is withdrawn in light of Applicant’s amendment of Claim 1 to limit the TLR agonists to PAM2CSK4 and ODNM362.
The prior rejection of Claim 12 under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007, see IDS filed 11/06/2023), in view of Mudde et al., (US2015/0196636, filed 7/02/2013, see IDS filed 11/06/2023) is withdrawn in light of Applicant’s amendments.
The prior rejection of Claim 16 under 35 U.S.C. 103 as being unpatentable over Mills et al., (US2009/0176696, filed 4/18/2007), in view of Yamazaki et al. (PLoS, 2011, 4:1-10). Krishnaswamy et al. (Am J Respir Cell Mol Bio, 2012, 47:852-863) and Mudde et al., (US2015/0196636, filed 7/02/2013), in further view of Shirota et al., (J Imm, 2000, 164:5575-5582, see IDS filed 11/06/2023) is withdrawn in light of Applicant’s amendments.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-2, and 16 are rejected under 35 U.S.C. 101 as claiming the same invention as that of 1-3 of U.S. Patent No. 11,826,422 (Dickey et al., Patented 11/28/2023). This is a statutory double patenting rejection.
The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the method for treating type I hypersensitivity of cited patent is the same invention as the method for treating type I hypersensitivity of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims.
Since the instant application claims are claiming identical subject matter as cited patent claims, said claims are not patentably distinct.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 12, 16-18 are rejected on the grounds of nonstatutory double patenting over claims 1-5 of U.S. Patent No. 11,826,422 (Dickey et al., Patented 11/28/2023).
The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the methods for treating type I hypersensitivity of cited patent anticipate the method of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 6/24/2026 are acknowledged and request that the rejection be held in abeyance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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